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The account reported pvp leakage within the pack, and the complaint stated that the pvp bottle had leaked all over the inside of 2 of the packs; the issue did not occur during patient use and no injury occurred.A photo and two unopened packs were received for evaluation; the photos showed brown staining on the exterior of the csr wrap surrounding the pvp solution, and upon opening the samples, visible pvp staining and evidence of leakage were observed.Finished good production records and finished good pack build were reviewed, and no non-conformances or issues were identified that could have contributed to the reported issue; based on photo and sample evaluation, medline confirmed the reported issue.Further evaluation determined that the root cause is a vendor-related product issue associated with the component manufacturing process; however, the component manufacturing facility reviewed production records, equipment setup parameters, and retained samples, found no discrepancies or leaks, and was unable to confirm the reported issue.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.
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